Apparatus for Applying Wound Treatment Material Using Tissue-Penetrating Needles

ABSTRACT

A surgical apparatus is provided including a disposable loading unit selectively operatively engagable within a distal end of a first half-section; and a wound treatment material applicator assembly for delivering wound treatment material to the target surgical site. The disposable loading unit includes a cartridge; a plurality of deployable needles supported within the cartridge, wherein each needle includes a lumen extending therethrough and at least one hole formed in an outer periphery thereof; and an actuation member translatably disposed within the cartridge for delivering a driving force to each needle to deploy the needles from the cartridge. The applicator assembly includes a first and second reservoir supported on the distal end of a respective first and second half-section; and a source of wound treatment material in fluid communication with each reservoir.

CROSS-REFERENCE TO RELATED APPLICATION

The present disclosure claims the benefit of and priority to U.S.Provisional Application 60/620,170, filed Oct. 18, 2004, the entirecontents of each of which being incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments, and moreparticularly, to a surgical apparatus capable of clamping body tissueand applying a wound treatment material thereto.

2. Description of the Related Art

Surgical procedures requiring cutting of tissue can result in bleedingat the site of the cutting. Various techniques have been developed tosuccessfully control bleeding, such as, for example, suturing, applyingclips to blood vessels, and using surgical fasteners, as well aselectrocautery and other tissue heating techniques.

Surgical devices using surgical fasteners entail grasping or clampingtissue between opposing jaw structure and then joining the tissue byemploying the surgical fasteners. These devices are well known in theart. In some instruments a knife is provided to cut the tissue which hasbeen joined by the fasteners. The fasteners are typically in the form ofsurgical staples however, two part polymeric fasteners are alsoutilized.

Instruments for this purpose can comprise two elongated members whichare respectively used to capture or clamp tissue. Typically, one of themembers carries a cartridge which houses a plurality of fastenersarranged in at least two lateral rows while the other member comprisesan anvil which defines a surface for forming the fastener legs as thefasteners are driven from the cartridge. Where two part fasteners areused, the anvil carries the mating part, e.g. the receiver, of thefasteners which are driven from the cartridge. Generally, the staplingoperation is effected by a pusher which travels longitudinally throughthe cartridge carrying member, with the pusher acting upon the staplesto sequentially eject them from the cartridge. A knife may travel withthe pusher between the staple rows to longitudinally cut (i.e., form aknife cut line) the stapled tissue between the rows of staples. Suchinstruments are disclosed in U.S. Pat. Nos. 3,079,606 and 3,490,675, theentire contents of each of which are incorporated herein by reference.

A later stapler disclosed in U.S. Pat. No. 3,499,591 provides a doublerow of staples on each side of the incision or the knife cut line. Thisis accomplished by providing a cartridge assembly in which a cam membermoves through an elongate guide path between two sets of staggeredstaple carrying grooves. Staple drive members are located within thegrooves and are positioned in such a manner so as to be contacted by thelongitudinally moving cam to effect ejection of the staples. Otherexamples of staplers are disclosed in U.S. Pat. Nos. 4,429,695,5,065,929, and 5,156,614, the entire contents of each of which areincorporated herein by reference.

Electrocautery devices are preferred in certain surgical procedures foreffecting improved hemostasis by heating tissue and blood vessels usingthermogenic energy, preferably radiofrequency energy, to causecoagulation or cauterization. Monopolar devices utilize one electrodeassociated with a cutting or cauterizing instrument and a remote returnelectrode, usually adhered externally to the patient. Bipolarinstruments utilize two electrodes and the cauterizing current isgenerally limited to tissue between the two electrodes of a tissuetreating portion (e.g., end effector) of an instrument.

Hemostatic electrosurgical stapling devices combining the structural andfunctional aspects of stapling instruments and electrocautery devicesgenerally provide improved hemostasis by using thermogenic energy tocause coagulation or cauterization at or in proximity to the knife cutline and surgical fasteners to staple the tissue, either before, duringor after the use of thermogenic energy.

Even though stapling, electrocauterizing or a combination of bothtechniques are generally well suited to control bleeding along the knifecut line, other techniques are envisioned for being used to controlbleeding during surgical procedures.

Therefore, it is an aspect of the present disclosure to provide asurgical apparatus for providing hemostasis, tissue joining or weldingwhich does not use conventional techniques.

SUMMARY

The present disclosure relates to surgical apparatus capable of clampingbody tissue and applying a wound treatment material thereto.

According to an aspect of the present disclosure, a surgical apparatusis provided including a first half-section adapted to receive adisposable loading unit in a distal end thereof; a second half-sectionin juxtaposed relation to the first half-section; a disposable loadingunit selectively operatively engagable with the distal end of the firsthalf-section; and a wound treatment material applicator assembly fordelivering wound treatment material to the target surgical site.

The disposable loading unit includes a cartridge; a plurality ofdeployable needles supported within the cartridge, wherein each needleincludes a lumen extending therethrough and at least one hole formed inan outer periphery thereof; a needle pusher in operative associationwith each needle for deploying each needle from the cartridge and into atarget tissue; and an actuation member translatably disposed within thecartridge for delivering a driving force to each needle pusher to deploythe needles from the cartridge.

The applicator assembly includes a first and second reservoir supportedon the distal end of a respective first and second half-section; and asource of wound treatment material in fluid communication with eachreservoir.

The source of wound treatment material may include at least onepressurized canister of wound treatment material. Each canister may besupported on one of the first and second half-sections.

Each needle pusher includes an opening formed therein for fluidcommunication with the lumen of the respective needle.

The distal end of the first half-section includes a plurality ofopenings provided between the reservoir and the cartridge supportedthereon for enabling transmission of wound treatment material from thereservoir to the cartridge. A plate including a plurality of needlereceiving openings may be supported on the distal end of the secondhalf-section. Accordingly, a distal end of each needle may enter arespective needle receiving opening of the second half-section duringoperation of the surgical apparatus.

An elastomeric material may be provided to confine the wound treatmentmaterial within the reservoir supported on the distal end of the secondhalf-section. Accordingly, upon actuation of the surgical apparatus, adistal end of each needle penetrates the elastomeric material and thelumen of each needle is in fluid communication with the reservoirsupported on the distal end of the second half-section.

The wound treatment material is at least one of an adhesive, a sealant,a hemostat, and a medicament.

The disposable loading unit may include a biasing member operativelyassociated with at least one of the needles for biasing the needles to aretracted condition. The surgical apparatus may further include a knifeblade supported on the actuation sled for severing tissue clampedbetween the distal ends of the first and second half-sections. The knifeblade may travel along a longitudinal slot provided in the cartridge. Itis envisioned that at least some needles are disposed on either side ofthe longitudinal slot of the cartridge.

The applicator assembly may include a valve fluidly interposed betweenthe source of wound treatment material and the reservoir.

According to another aspect of the present disclosure, a method ofoperating on tissue at a target surgical site is provided. The methodincludes the step of providing a surgical apparatus. The surgicalapparatus includes a disposable loading unit selectively operativelysupportable in a distal end of a first half-section, the disposableloading unit having a cartridge operatively supporting a plurality ofdeployable needles, wherein each needle includes a lumen extendingtherethrough and at least one hole formed in an outer periphery thereof,and an actuation member translatably disposed within the cartridge fordelivering a driving force to each needle to deploy the needles from thecartridge. The surgical apparatus further includes a wound treatmentmaterial applicator assembly for delivering wound treatment material tothe target surgical site. The applicator assembly includes at least onereservoir supported on a distal end of one of a first and secondhalf-section, and a source of wound treatment material in fluidcommunication with each reservoir;

The method further includes the steps of clamping adjacent layers oftissue between a distal end of a first and a second half-section of thesurgical apparatus; firing the surgical apparatus, wherein firing of thesurgical apparatus includes distally advancing the actuation member todrive the plurality of needles through the clamped tissue, anddispensing wound treatment material to the clamped tissue from thesource of wound treatment material, through the plurality of needles.

The source of wound treatment material may be pressurized. Accordingly,upon firing the surgical apparatus the wound treatment material isexpelled from the source thereof Additionally, upon firing of thesurgical apparatus a distal end of each needle desirably enters a distalend of the second half-section.

The surgical apparatus may include a reservoir supported on a distal endof each of the first and second half-sections. Accordingly, the woundtreatment material may be delivered to the lumen of each needle fromeach of the reservoirs.

The surgical apparatus may further include a knife blade translatablymovable along the distal ends of the first and second half-sections tosever tissue clamped therebetween, wherein upon firing the surgicalapparatus the knife blade is distally advanced along the distal ends ofthe first and second half-sections to sever the tissue clampedtherebetween.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the surgical apparatus will be describedhereinbelow with reference to the drawings wherein:

FIG. 1 is a perspective view of a surgical apparatus having a woundtreatment material applicator constructed in accordance with a preferredembodiment with the clamping handle thereof disposed in an upright openposition;

FIG. 2 is a perspective view of the surgical apparatus illustrated inFIG. 1 with the clamping handle disposed in a closed position;

FIG. 3 is an exploded perspective view of the surgical apparatus ofFIGS. 1 and 2;

FIG. 4 is an exploded perspective view of the lower body portion of thesurgical apparatus of FIGS. 1 and 2;

FIG. 5 is a cross-sectional view of the anvil components as would beseen along line 5-5 in FIG. 3;

FIG. 6 is a cross-sectional view of cartridge components construed, andas would be seen along line 6-6 in FIG. 3;

FIG. 7 is an enlarged perspective and partial vertical cross-sectionalview with parts broken away of a portion of the adhesive applicator ofthe surgical apparatus of FIGS. 1 and 2;

FIG. 8 is an enlarged side view with portions broken away showing thesurgical apparatus of FIGS. 1 and 2 clamping and applying adhesive tobody tissue;

FIG. 9 is an enlarged sectional view of a portion of the wound treatmentmaterial applicator as would be seen along line 9-9 of FIG. 8 showingapplication of wound treatment material by the wound treatment materialapplicator to adjoin body tissue;

FIG. 10 is a schematic illustration of a distal end of a surgicalapparatus including a wound treatment material applicator constructed inaccordance with an alternate embodiment of the present disclosure; and

FIG. 11 is a schematic illustration of a distal end of a surgicalapparatus including a wound treatment material applicator constructed inaccordance with another alternate embodiment of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure provides a surgical apparatus which usesbiological and/or synthetic biocompatible sealants, hemostats andadhesives (collectively referred to herein as wound treatment materials)for providing hemostasis, tissue joining or welding. The use of woundtreatment materials provides short and long-term hemostasis and sealing,and/or reduces or prevents bleeding along a knife cut line.

In the drawings and in the following description, the term “proximal”,as is traditional, will refer to the end of the apparatus which iscloser to the operator, while the term “distal” will refer to the end ofthe apparatus which is further from the operator.

Referring now to the drawings wherein like reference numerals identifysimilar structural elements, there is illustrated in FIGS. 1 and 2 asurgical apparatus 10, having a wound treatment material applicatorconstructed in accordance with a preferred embodiment, is illustrated.Surgical apparatus 10 includes a cartridge or needle-releasinghalf-section 11 a (hereinafter referred to as first half-section) and ananvil or needle-receiving half-section 11 b (hereinafter referred to assecond half-section). As will become readily apparent to those havingordinary skill in the art, apparatus 10 is constructed in such a mannerso as to substantially reduce the costs associated with its fabricationand assembly.

Referring to FIGS. 1-3, integral with first half-section 11 a, apparatus10 includes a body portion 12 defining a handle for grasping andsupporting the device. A retaining channel 14 is mounted in the interiorcavity 15 of body portion 12 adjacent the distal end thereof. Retainingchannel 14 is dimensioned and configured to support a disposable loadingunit 20.

As shown in FIGS. 4, 7 and 9, disposable loading unit 20 includes acartridge 22 having a plurality of slots 22 a, 22 b which retain aplurality of surgical needles 24. The disposable loading unit 20 furtherincludes a plurality of needle pushers 26 adapted and configured to pushor deploy needles 24 outside of or out through the slots 22 a, 22 b whenacted upon by a driving force. Needle pushers 26 are also configured anddimensioned to feed wound treatment material “W” into the interior ofneedles 24 via central openings 154 formed in pushers 26 (see FIG. 9).The disposable loading unit 20 further includes an actuation member 28(FIGS. 3, 4 and 8), here shown, for example, as a sled, mounted totranslate through cartridge 22 in a longitudinal direction to transmit adriving force to pushers 26 for applying or dispensing wound treatmentmaterial “W” to a surgical application site from or through holes 121 onthe periphery of the needles 24 (see FIG. 9). While actuation member 28is shown as a sled, it is envisioned and within the scope of the presentdisclosure for actuation member 28 to be cam rollers, cam slides and thelike, as will be described in greater detail below with reference toFIG. 10.

Referring back to FIGS. 1-3, wound treatment material “W”, or acomponent thereof, is supplied to the surgical application site by anapplicator assembly 2. Applicator assembly 2 includes a pair ofreservoirs 4 a, 4 b in fluid communication with respective distal endsof first and second half-sections 11 a, and 11 b. Reservoirs 4 a, 4 bare in fluid communication with pressure-actuating fluid (gas or liquid)canisters 6, via conduit assemblies 8. Preferably, the fluid is a gas.An upper and a lower conduit 8 a, 8 b, respectively, (see FIGS. 2 and 3)of conduit assembly 8, extend from canister 6, and feed into arespective reservoir 4 a, 4 b of applicator assembly 2 for deliveringpressurized fluid thereto. Each canister 6 is releasably mounted to arespective mounting member or track 91 that is part of or affixed tobody portion 12. Each canister 6 includes a nozzle 124 (see FIG. 3)having a valve 126 for controlling the flow of pressurized fluidcontained therein to reservoirs 4 a, 4 b via conduit assemblies 8. Therelease of the pressurized fluid, from canisters 6, forces woundtreatment material “W” through needles 24 during a surgical woundtreatment material applying operation.

In order to provide wound treatment material “W” from reservoir 4a tothe interior of retaining channel 14, as seen in FIGS. 6 and 7,retaining channel 14 includes, preferably initially sealed, openings 150formed along a base portion 60 thereof for passage of wound treatmentmaterial “W” from reservoir 4 a mounted below retaining channel 14. Inuse, in accordance with a method of the present disclosure, afterremoval, breakage, penetration or otherwise providing access or passagethrough a seal 61 (see FIG. 6) overlying base portion 60, woundtreatment material “W” flows from reservoir 4 a into the interior ofretaining channel 14, through openings 150 due to the pressure providedby the pressurized fluid of canisters 6, and finally into and throughthe interior of needles 24 before being dispensed with, onto, above,below and/or between layers of tissue 120 (see FIG. 9).

In a preferred embodiment, one of reservoirs 4 a, 4 b stores onecomponent of a wound treatment material “W” used in forming a two-partadhesive, e.g., a glue, while the other of reservoirs 4 a, 4 b stores asecond component of the wound treatment material “W” used in forming thetwo-part adhesive, e.g., an accelerator. In another preferredembodiment, as seen in FIG. 6, a first compartment 156 of each reservoir4a and/or 4 b stores one component of a wound treatment material forforming an adhesive while a second compartment of each reservoir 4 aand/or 4 b stores a second component of the wound treatment materialused in forming the adhesive. Preferably, the first and secondcomponents are fed to a common needle for application/delivery of thecombined components to or at the treatment site.

Preferably, reservoirs 4 a, 4 b are identical and encase an equal,complimentary or suitable volumetric amount of respective components ofwound treatment material “W” to obtain and/or maintain a predeterminedratio of the first component to the second component, which ratio may be1:1. Also, preferably, the adhesive formed by the two components ofwound treatment material “W” is fibrin glue or fibrin sealant which actsas a hemostatic agent and as a tissue adhesive.

Fibrin sealant is formed by a rapid polymerization which occurs when asolution of proteomic clotting factors, such as fibrinogen, comes intocontact with a solution of a proteomic catalyst, such as thrombin. Thisrapid polymerization typically commences within two seconds after thesolutions initially contact one another, and it typically attains a softset within ten seconds of contact. Because of the rapid polymerizationupon intimate interaction of fibrinogen and thrombin, it is important tomaintain these two blood proteins separate until applied at theapplication site. Accordingly, it is preferred that applicator assembly2 supplies each blood protein separately from the other blood protein byusing a separate conduit assembly for each protein and bycompartmentalizing surgical needles 24 to prevent mixing of the twocomponents prior to being applied to the application site.

It is contemplated that the wound treatment material “W” is any materialfor joining, healing, sealing or otherwise treating tissue. In apreferred embodiment, the wound treatment material is a bio-compatiblesealant, including, and not limited, to sealants which cure upon tissuecontact, sealants which cure upon exposure to ultraviolet (UV) light,sealants which are two-part systems which are kept isolated from oneanother and are combined or any combinations thereof Any known suitableadhesive may be used. In one embodiment, it is contemplated that suchsealants and/or adhesives are curable. For example, sealants may have acure time of from about 10 to 15 seconds may be used. In preferredembodiments, the sealant and/or adhesive is a bioabsorbable and/orbio-resorbable material. In another embodiment, it is contemplated thata sealant and/or adhesive having a cure time of about 30 seconds may beused. It is further envisioned that wound treatment material “W” may bea pre-cured adhesive or sealant. The pre-cured adhesive or sealant mayreact with the moisture and/or heat of the body tissue to therebyactivate the sealing and/or adhesive properties of the sealant oradhesive.

In certain preferred embodiments, the wound treatment material comprisesa sealant. Such a sealant is desirably a PEG-based material. Examples ofclasses of materials useful as the sealant and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulthydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc.

Some specific materials which may be utilized include isocyanateterminated hydrophilic urethane prepolymers derived from organicpolyisocyanates and oxyethylene-based diols or polyols, including thosedisclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 and U.S. PublishedPatent Application No. 2004/0068078; alpha-cyanoacrylate based adhesivesincluding those disclosed in U.S. Pat. No. 6,565,840; alkyl ester basedcyanoacrylate adhesives including those disclosed in U.S. Pat. No.6,620,846; adhesives based on biocompatible cross-linked polymers formedfrom water soluble precursors having electrophilic and nucleophilicgroups capable of reacting and cross-linking in situ, including thosedisclosed in U.S. Pat. No. 6,566,406; two part adhesive systemsincluding those based upon polyalkylene oxide backbones substituted withone or more isocyanate groups in combination with bioabsorbable diaminecompounds, or polyalkylene oxide backbones substituted with one or moreamine groups in combination with bioabsorbable diisoycanate compounds asdisclosed in U.S. Published Patent Application No. 2003/0032734, thecontents of which are incorporated by reference herein; and isocyanateterminated hydrophilic urethane prepolymers derived from aromaticdiisocyanates and polyols as disclosed in U.S. Published PatentApplication No. 2004/0115229, the contents of which are incorporated byreference herein.

It is envisioned and within the scope of the present disclosure thatwound treatment material “W” may include one or a combination ofadhesives, hemostats, sealants, or any other tissue or wound-treatingmaterial. Surgical biocompatible wound treatment materials “W”, whichmay be used in accordance with the present disclosure, include adhesiveswhose function is to attach or hold organs, tissues or structures,sealants to prevent fluid leakage, and hemostats to halt or preventbleeding. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

The medicament may include one or more medically and/or surgicallyuseful substances such as drugs, enzymes, growth factors, peptides,proteins, dyes, diagnostic agents or hemostasis agents, monoclonalantibodies, or any other pharmaceutical used in the prevention ofstenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerinthereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

It is envisioned that wound treatment material “W” may be a relativelylow viscosity fluid or liquid such that the wound treatment material “W”may freely flow through conduits 8 and/or needles 24. It is furtherenvisioned that wound treatment material “W” may include a fine powderof particulate material.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

Cartridge 22 is preferably fabricated from a liquid crystal polymermaterial, although other materials are contemplated. Cartridge 22 has alip 23 which engages the retention channel 14 to secure, stabilize and,e.g., prevent inward rotation of cartridge 22.

As seen in FIGS. 3 and 4, for simplicity and ease of manufacturing andassembly, actuation sled 28 is preferably monolithically formed from asingle piece of sheet metal which is folded into the desired structuralconfiguration. In this configuration, actuation sled 28 defines a baseportion 30, two upstanding cam wedges 32 and 34, and an upstanding shank35 which supports a knife blade 36. Knife blade 36 is preferably spotwelded to shank 35, although other known fastening methods may beemployed.

Cam wedges 32 and 34 are axially staggered with respect to one anotherso that one leads the other throughout the sled's translation throughcartridge 22. In doing so, the driving forces within cartridge 22 remainbalanced during a surgical driving operation. Longitudinal slots 22 aand 22 b accommodate the longitudinal translation of cam wedges 32 and34, while slot 22 c accommodates the longitudinal translation of shank35.

The base portion of actuation sled 28 has a transverse slot 40 definedtherein which is dimensioned and configured to releasably retain anupturned flange 42 formed at the distal end of elongated actuationchannel 44 (see FIG. 4). When the disposable loading unit 20 is placedinto retaining channel 14 and actuation sled 28 is disposed in itsproximal-most position, flange 42 releasably engages slot 40. Thus,movement of actuation channel 44 moves actuation sled 28 which, in turn,engages pushers 26 to deploy needles 24. After an adhesive applicationoperation, disposable loading unit 20 can be removed from the retainingchannel by easily disengaging flange 42 from slot 40.

With continued reference to FIG. 4, actuation channel 44 is defined by abase portion 45 and two parallel upstanding beams 46 and 48 of elongateconfiguration. The distal ends of beams 46 and 48 are staggered to matchthe staggered orientation of cam wedges 32 and 34, respectively. Theproximal end of each beam 46, 48 projects rearwardly to engage amounting block 49 that is associated with a firing knob 50. A pair ofslots 52 (only one of which is shown) are formed in mounting block 49for receiving the proximal end of each of the upstanding beams 46, 48 ofactuation channel 44. Slots 52 are provided with detents 54 for engagingapertures 56 in the beam ends to lockingly retain beams 46, 48 inmounting block 49. In use, longitudinal movement of firing knob 50causes corresponding longitudinal translation of actuation channel 44and actuation of sled 28.

Referring to FIGS. 3 and 6, retention channel 14 includes a base portion60 and two upstanding parallel walls 62 and 64. Numerical indicia areimprinted on the walls 62, 64 of retention channel 14 to indicate thelength of the adhesive line. Retention structures are provided at thedistal end of each of the walls 62, 64 to engage correspondingstructures provided on the disposable loading unit 20. In particular,notches 66 a and 66 b are provided for engaging correspondingprotuberances, such as protuberance 67, and slots 68 a and 68 b areprovided for engaging corresponding detents, such as detent 69. Thesestructures inhibit lateral, longitudinal and perpendicular shifting ofthe cartridge 22 (and disposable loading unit 20) within the retainingchannel 14.

Ramped engagement slots 70 a and 70 b are also defined in the opposedwalls of retention channel 14 for interacting with a pair of opposedprotuberances 72 a and 72 b (see FIGS. 3 and 4) to guide the disposableloading unit 20 into retention channel 14 when loaded into the surgicalapparatus 10.

With continued reference to FIG. 3, surgical apparatus 10 furtherincludes an elongate anvil support beam 80 which has a generallyU-shaped cross-sectional configuration. Proximal end portion 82 ofsupport beam 80 has a notched area 84 for engaging a pair ofcorresponding detents 86 (only one being shown) which extend into thecavity 15 of body portion 12 adjacent the proximal end thereof. Detents86 are engaged when cartridge or first half-section 11 a and anvil orsecond half-section 11 b is mated with one another. Distal end portion88 of anvil support beam 80 is configured to support a preformed plate90 having a plurality of openings 141 (see FIG. 9) in juxtaposedalignment with a respective needle 24 for receiving a portion of theneedle 24 therein during the surgical procedure.

Plate 90 is preferably formed from a unitary piece of metal and is coldformed and stamped to define the plurality of needle receiving openings141 (see FIG. 5). Each needle receiving opening 141 is in alignment witha particular needle 24 housed within cartridge 22. Plate 90, as shown inFIG. 3, is provided with two opposed tangs 92 a and 92 b which extendinwardly to engage complementary engagement slots 93 b (only one beingshown) in anvil support beam 80 during fabrication and assembly. Thecross-sectional configuration of plate 90 is dimensioned to complementthe cross-sectional geometry of support beam 80 (see FIG. 5). Moreparticularly, cavity 93 which extends along the length of plate 90corresponds to a similar channel formed in support beam 80. These areasaccommodate shank 35 and knife blade 36 as it translates distally toform an incision in the body tissue, which incision is adjoined byadhesives during a surgical adhesive-applying operation.

A pair of rectangular apertures 95 a and 95 b are formed in plate 90adjacent the proximal end thereof for receiving a pair ofcorrespondingly positioned flanges or projections 96 a and 96 b whichproject upwardly away from tissue contacting surface 97 (see FIGS. 3 and4). The interaction between apertures 95 a, 95 b and flanges 96 a, 96 bensures that cartridge 22 and plate 90 are properly aligned with oneanother during a surgical adhesive-applying procedure.

A bottom surface 160 of the top reservoir 4 b preferably is fabricatedfrom an elastomeric or other suitable material 161. Bottom surface 160is attached to anvil support beam 80. During a surgicaladhesive-applying procedure, needles 24 penetrate elastomeric material161 of reservoir 4 b and pressurized adhesive flows into the interior ofneedles 24 (see FIG. 9). It is envisioned that elastomeric material 161can include a series of weakened lines formed therein and inregistration with needles 24. In this manner, a reduced force isrequired for needles 24 to penetrate elastomeric material 161.

After needles 24 dispense wound treatment material “W”, needles 24 areretracted into disposable loading unit 20 and elastomeric material 161reseals reservoir 4 b to free tissue 120, 122 from needles 24 and toprevent spillage of the remaining adhesive contained in reservoir 4 b.In one embodiment, needles 24 can exit reservoir 4 b by the surgeonincreasing pressure from reservoir 4 b to force needles 24 back intodisposable loading unit 20. In another embodiment, a spring 98 (see FIG.7) can be suitably disposed and/or suitably positioned about each needle24 to return the needles 24 to the undeployed condition upon retractionof actuation sled 28. In particular, in use, when actuation sled 28 isadvanced to displace pushers 26, the springs 98 are compressed andmaintained compressed by beams 46, 48 of actuation channel 44 remainingin contact with pushers 26. When actuation sled 28 is withdrawnproximally, after the application of wound treatment material “W”,springs 98 expand and thereby move or retract needles 24 back intodisposable loading unit 20.

Referring to FIGS. 1-3, anvil or second half-section 11 b of apparatus10 further includes clamping handle 100 which is used to securely clamptissue between the surface of plate 90 and tissue contacting surface 97of cartridge 22. Clamping handle 100 is pivotably mounted to anvilsupport beam 80 about a transverse pivot pin (not shown). A pair ofclamping hooks 102 a and 102 b depend from clamping handle 100 forinteracting with U-shaped clamping beam 104 supported within theinternal cavity defined in body portion 12.

When apparatus 10 is assembled prior to use, notched area 84 at proximalend 82 of anvil support beam 80 is engaged with the cooperating detents86 in the inner cavity 15 of body portion 12. Thereupon, anvil or secondhalf-section 11 b is mated with cartridge or first half-section 11 a,and clamping handle 100 is disposed in the upright unclamped positionshown in FIG. 1. Subsequently, when body tissue is properly disposedbetween the surface of plate 90 and tissue contacting surface 97 ofcartridge 22, anvil or second half-section 11 b is pivoted towardscartridge or first half-section 11 a, about the detents in body portion12, such that the distal ends of clamping hooks 102 a and 102 b arepositioned immediately adjacent the proximal end of the base of U-shapedclamping beam 104. Concomitantly, flanges 96 a and 96 b engage apertures95 a and 95 b in plate 90 to ensure proper alignment of the anvil andthe cartridge.

Then, to securely clamp the captured body tissue, clamping handle 100 ispivoted from the position illustrated in FIG. 1 to that which is shownin FIG. 2. At such a time, clamping hooks 102 a and 102 b engage thebase of clamping beam 104, locking the apparatus 10 in a clampedcondition. During clamping, the captured body tissue exerts acounter-force against tissue contacting surface 97 of cartridge 22 andthe fastener forming surface of the plate 90, urging the two structuresapart. To overcome these forces and prevent the proximal portion 82 ofanvil support beam 80 from bending, bearing surfaces are defined withinretention channel 14 to support the compressive forces generated duringclamping. In particular, as illustrated in FIG. 3, opposed bearingshelves 110 a and 110 b are stamp formed in opposed walls 62 and 64 ofretention channel 14. The bearing shelves 110 a, 110 b are positioned toabut the medial section of anvil support beam 80 proximate the clampinghandle pivot point. It is desirable to provide a locking mechanism toprevent reactuation of the apparatus after it has been actuated.

Referring now to FIGS. 7-9, there is illustrated, a method of applying asurgical wound treatment material “W”, here an adhesive. According tothe procedure a plurality of needles 24 are deployed or pushed fromcartridge 22, by actuation sled 28 or by cam wedges or surfaces 32 a, 34a (see FIG. 4), through needle exit holes 122 and are driven into tissue120 before, during or after being received by the needle-receivingopenings 141 of plate 90. Meanwhile, knife blade 36 (see FIG. 4) cutsthrough tissue 120 forming a knife cut line along slot 22 c. Inoperation, prior to firing surgical apparatus 10, actuation sled 28 isin the proximal-most position. At such a time, knife blade 36 isenclosed in protective housing 25 (see FIGS. 3 and 4) formed adjacentthe proximal end of disposable loading unit 20.

In order to fire surgical apparatus 10, after tissue 120 has beenclamped between the distal ends of first and second half-sections,firing knob 50 is moved in a distal direction. Accordingly, asillustrated in FIG. 8, upon moving firing knob 50 in a distal direction,actuation channel 44 drives actuation sled 28 distally into and throughcartridge 22. During its distal translation, the angled leading surfacesof cam wedges 32 and 34 sequentially contact pushers 26, urging them ina direction transverse to the direction of movement of actuation sled28. As a result, pushers 26 push needles 24 from their individual exitholes 122, driving needles 24 into tissue 120 before being received bycorresponding needle-receiving openings 141 provided in plate 90 (seeFIG. 9).

Sequential firing of needles 24 continues until actuation sled 28 isadvanced to the distal-most end of cartridge 22, at which time, all ofthe needles 24, once housed within cartridge 22, have been pushed out ofdisposable loading unit 20 and a knife cut line has been formed intissue 120 by knife blade 36. The knife cut line and exterior, interiorand/or interstitial regions of tissue 120, as desired, are supplied withadhesive by opening valve 126 and allowing pressurized fluid containedin each canister 6 to be released into reservoirs 4 a, 4 b to therebyforce wound treatment material “W”, here shown for example as adhesive“A”, or each component of adhesive “A₁, A₂”, into the region(s) betweentissue 120, through needles 24 and through holes 121 as well as to theknife cut line through slot 22 c. Valve 126 is maintained open untileither sufficient adhesive “A” is dispensed, the entire adhesive “A” isdispensed, and/or all of the pressure within canister 6 is depleted.

Thereafter, firing knob 50 is retracted to its original position,causing needles 24 to be retracted into disposable loading unit 20,e.g., by way of a compression spring or other biasing means 98 disposedbetween needle pushers 26 and an inner surface of tissue contactingsurface 97 of disposable loading unit 20, the first and secondhalf-sections are separated, and disposable loading unit 20, as well asone or both reservoirs 4 a, 4 b, may be removed from retaining channel14. Preferably, biasing means 98 are disposed about each needle 24 ofeach pusher 26. Subsequently, a new, fully loaded disposable loadingunit 20 can be positioned in retaining channel 14 such that the slot 40of actuation sled 28 engages flange 42 of actuation channel 44 to enablere-use of the apparatus 10.

It is envisioned that canisters 6 can also be replaced as needed.Alternatively, it is envisioned that reservoirs 4 a, 4 b can be fluidlycoupled to a remote pressure source (not shown), thereby obviating theneed for canisters 6. In yet another embodiment, it is envisioned thatreservoirs 4 a, 4 b can be fluidly coupled to a hand actuated pressuresource, e.g., a syringe, hand pump, etc.

Although the subject apparatus has been described with respect topreferred embodiments, it will be readily apparent to those havingordinary skill in the art to which it appertains that changes andmodifications may be made thereto without departing from the spirit orscope of the subject apparatus. For example, the invention may beapplied to endoscopic as well as open-type surgical, e.g., anastomosis,apparatus. The invention may be easily applied to hand-held manually orremotely, e.g., robotically, operated endoscopic linear staplers thatemploy, e.g., a pair of jaws, e.g., an anvil and a cartridge, forsequentially or simultaneously applying a wound treatment material to atissue treatment site.

It is further envisioned that reservoirs 4 a, 4 b may be pressurizedwhen the handle(s) 100 of apparatus 10 are actuated to close and/orotherwise clamp apparatus 10 onto tissue 120. For example, handle(s) 100of apparatus 10 may act like manual pumps to force additional fluid(e.g., gas or liquid) into reservoirs 4 a, 4 b thereby increasing thepressure within reservoirs 4 a, 4 b. Accordingly, when needles 24penetrate seals 61, 161, the wound treatment material “W” is forced outof reservoirs 4 a, 4 b.

Turning now to FIG. 10, in an alternate embodiment, surgical apparatus10 includes a camming device 150, including a cam roller 152,translatably disposed within body portion 12. In operation, after thedistal ends of the first and second-half sections 11 a, 11 b of surgicalapparatus 10 have been clamped onto tissue 120, camming device 150 isadvanced distally through body portion 12 and disposable loading unit 20to deploy needles 24. Desirably, six (6) rows of needles 24 may beprovided which extend substantially the entire length of the distal endsof the first and second-half sections 11 a, 11 b. Once needles 24 havebeen deployed, wound treatment material “W”, in the form of glue and anaccelerator may be driven or fed through respective distal ends of thefirst and second-half sections 11 a, 11 b and into needles 24 where thetwo components mix when exiting the perforations formed in needles 24 tojoin or seal the tissue. Finally, a knife (not shown) may be provided todissect the tissue into two halves along the middle of the distal endsof the first and second-half sections 11 a, 11 b. Flow of pressurizedfluid and/or of wound treatment material “W” may be activated by signalsfrom one or more suitably situated and activated sensors.

Turning now to FIG. 10, an alternate embodiment of surgical apparatus 10is shown and described. Surgical apparatus 10 may include a first fluiddelivery channel 162 extending through the distal end of the firsthalf-section 11 a, and a second fluid delivery channel 164 extendingthrough a distal end of the second half-section 11 b. Desirably, firstfluid delivery channel 162 is in fluid communication with at least some,preferably, each staple receiving/forming pocket 166 formed in a tissuecontacting surface of the distal end of first half-section 11 a.Additionally, second fluid delivery channel 164 is in fluidcommunication with at least some, preferably each staple retaining slot168 provided in a tissue contacting surface of the distal end of secondhalf-section 11 b. A surgical staple 170 is desirably disposed in eachstaple retaining slot 168. As is conventional, each staple retainingslot 168 is in juxtaposed alignment with each staple receiving/formingpocket 166.

Each channel 162, 164 is fluidly connected to the same or individualfluid sources (not shown), for example as described above. In thismanner, fluid in the form of wound treatment material “W” may bedelivered to staple retaining slots 168 and/or staple receiving/formingpockets 166 via respective channels 162, 164.

Accordingly, in use, upon firing surgical apparatus 10, staples 170 aredeployed from staple retaining slots 168 to penetrate through tissue andto be formed within stapler receiving/forming pockets 166. Concomitantlytherewith, wound treatment material “W” is dispensed from stapleretaining slots 168 and/or staple receiving/forming pockets 166, asdescribed above.

It will be understood that various modifications may be made to theembodiments of the surgical apparatus disclosed herein. Therefore, theabove description should not be construed as limiting, but merely asexemplifications of embodiments. Those skilled in the art will envisionother modifications within the scope of the present disclosure.

1-21. (canceled)
 22. A surgical apparatus, comprising: a first sectionand a second section pivotably mounted in relation to the first sectionfor clamping tissue therebetween; a cartridge disposed in the secondsection and having a proximal end and a distal end, the cartridge havinga plurality of deployable needles supported within the cartridge,wherein each needle includes a lumen extending therethrough fordispensing a fluid; a plurality of pushers disposed in the cartridge,each of the pushers being in operative association with at least one ofthe needles for sequentially deploying the needles from the cartridgeand into tissue clamped between the first section and the secondsection; a reservoir defined in the second section adjacent the pushersof the cartridge, the reservoir containing the fluid; and a pressurizedcanister in fluid communication with the reservoir.
 23. The surgicalapparatus according to claim 22, wherein the canister is supported onthe second section.
 24. The surgical apparatus according to claim 22,wherein each pusher includes an opening formed therein allowing thefluid to pass from the reservoir to the respective needle.
 25. Thesurgical apparatus according to claim 22, further comprising anactuation member disposed within the cartridge for translation from theproximal end to the distal end of the cartridge thereby delivering adriving force to each pusher to sequentially deploy the needles from thecartridge.
 26. The surgical apparatus according to claim 22, wherein thefluid is a wound treatment material.
 27. The surgical apparatusaccording to claim 22, wherein the first section has a plate including aplurality of needle receiving openings.
 28. The surgical apparatusaccording to claim 27, wherein a distal end of each needle enters arespective needle receiving opening of the first section duringactuation of the surgical apparatus.
 29. The surgical apparatusaccording to claim 25, wherein the actuation member comprises a camroller that translates through the cartridge to interact with thepushers.
 30. The surgical apparatus according to claim 26, wherein thewound treatment material is at least one of an adhesive, a sealant, ahemostat, and a medicament.
 31. The surgical apparatus according toclaim 25, further comprising a knife blade supported on the actuationmember for severing tissue clamped between the first section and thesecond section, the knife blade traveling along a longitudinal slotprovided in the cartridge.
 32. The surgical apparatus according to claim31, wherein a first portion of the needles are disposed on one side ofthe longitudinal slot and at least a second portion of the needles aredisposed on the other side of the longitudinal slot.
 33. The surgicalapparatus according to claim 22, wherein the first section has a firstsection reservoir, a plurality of needles, and a plurality of pushers,the reservoir being in fluid communication with lumens extending throughthe needles of the first section.
 34. A surgical apparatus, comprising:a first section and a second section pivotably mounted in relation tothe first section for clamping tissue therebetween; a cartridge disposedin the second section and having a proximal end and a distal end, thecartridge having a plurality of members with tissue penetrating tipssupported within the cartridge; a plurality of pushers disposed in thecartridge, each of the pushers being in operative association with atleast one of the tissue penetrating members for sequentially deployingthe tissue penetrating members from the cartridge and into tissueclamped between the first section and the second section; and a camroller that translates through the cartridge to interact with thepushers, thereby deploying the tissue penetrating members from thecartridge.
 35. The surgical apparatus according to claim 34, furthercomprising a reservoir defined in the second section adjacent thepushers of the cartridge, the reservoir containing a fluid.
 36. Thesurgical apparatus according to claim 35, further comprising apressurized canister in fluid communication with the reservoir.
 37. Thesurgical apparatus according to claim 36, wherein the canister issupported on the second section.
 38. The surgical apparatus according toclaim 36, wherein each pusher includes an opening formed thereinallowing the fluid to pass from the reservoir to the respective tissuepenetrating member.
 39. The surgical apparatus according to claim 35,wherein the fluid is a wound treatment material.
 40. The surgicalapparatus according to claim 34, wherein the first section has a plateincluding a plurality of openings.
 41. The surgical apparatus accordingto claim 40, wherein a distal end of each tissue penetrating memberenters a respective opening of the first section during actuation of thesurgical apparatus.
 42. The surgical apparatus according to claim 39,wherein the wound treatment material is at least one of an adhesive, asealant, a hemostat, and a medicament.
 43. The surgical apparatusaccording to claim 34, further comprising a knife blade for severingtissue clamped between the first section and the second section, theknife blade traveling along a longitudinal slot provided in thecartridge.
 44. The surgical apparatus according to claim 43, wherein afirst portion of the tissue penetrating members are disposed on one sideof the longitudinal slot and at least a second portion of the tissuepenetrating members are disposed on the other side of the longitudinalslot.
 45. The surgical apparatus according to claim 34, wherein thefirst section has a first section reservoir, a plurality of tissuepenetrating members, and a plurality of pushers, the reservoir being influid communication with lumens extending through the tissue penetratingmembers of the first section.